FDA.reportPublic FDA data

Stylet

Primary DI
00792079000431
Brand
Stylet
Company
Medionics International Inc
Model
SST-650
Catalog number
SST-650
Published
2018-04-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GBWCatheter, Peritoneal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBWCatheter, PeritonealGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00792079000431PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00792079000431007920790004317920790004310792079000431

GMDN Terms#

Term, Definition table
TermDefinition
Peritoneal catheter styletA sterile thin wire/rod intended to be inserted within the lumen of a percutaneous peritoneal catheter (i.e., peritoneal dialysis catheter, peritoneal drainage catheter) to stiffen/maintain the shape of the catheter to assist introduction. It is intended to be removed once the catheter is in place. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
905-472-6544info@medionics.com

Regulatory Flags#

DUNS number
241421320
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00792079000639Peritoneal Dialysis CatheterCA-2272CA-22722026-02-02
00792079000752Peritoneal Dialysis Catheter AdapterPCA-1010PCA-10102026-02-02
00792079001827Faller StyletFS-404FS-4042026-02-02
00792079000424Faller StyletFS-401FS-4012018-04-09
00792079001216Faller StyletFS-402FS-4022018-04-09
00792079001223Faller StyletFS-403FS-4032018-04-09
00792079000028Peritoneal Dialysis CatheterSA-1247SA-12472018-04-09
00792079000035Peritoneal Dialysis CatheterSA-1248KSA-1248K2018-04-09
00792079000141Peritoneal Dialysis CatheterSI-1231SI-12312015-09-17
00792079000196Peritoneal Dialysis CatheterCA-2262CA-22622015-09-17
00792079000219Peritoneal Dialysis CatheterCA-1162CA-11622015-09-17
00792079000226Peritoneal Dialysis CatheterCA-1157CA-11572018-04-09
00792079000264Peritoneal Dialysis CatheterCP-1241CP-12412015-09-17
00792079000356Peritoneal Dialysis CatheterSNCA-5262LSNCA-5262L2015-09-17
00792079000363Peritoneal Dialysis CatheterSNCP-5243LSNCP-5243L2015-09-17
00792079000394Peritoneal Dialysis Catheter AdapterTA-200TA-2002018-04-09
00792079000400Peritoneal Dialysis Catheter AdapterTA-300TA-3002018-04-09
00792079000592Peritoneal Dialysis CatheterSNPS-53113SNPS-531132015-09-17
00792079000967Peritoneal Dialysis CatheterSNCA-5263LFDSNCA-5263LFD2018-04-09
00792079001476Peritoneal Dialysis CatheterPSNA-100PSNA-1002015-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885380208942JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380208959JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380208966JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380208973JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380208980JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380208997JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209000JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209017JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209024JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209031JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209048JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209055JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209062JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209079JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209086JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209093JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209109JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209116JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209123JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209130JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209147JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209154JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209161JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209178JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209185JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209192JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209208JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209215JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
14026704912794TAUTTELEFLEX INCORPORATEDGBW2024-06-19
14026704912800TAUTTELEFLEX INCORPORATEDGBW2024-06-19